Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208
FDA 510(k) K070091 · Cardinal Health, Inc.
510(k) numberK070091
Submission
- Device name
- Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208
- Applicant
- Cardinal Health, Inc.
Mcgaw Park, IL, US - Received
- January 10, 2007
- Decision date
- April 18, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNW – Instrument, Biopsy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208 cleared by the FDA?
Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208 (K070091) received a 510(k) decision of Substantially Equivalent on April 18, 2007, 98 days after the submission was received.
What is the product code of K070091?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.